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Federal Register / Vol. 46. No. 233 / Friday. December 4. 1981 / Notices 
of these Guidelines (see Footnote 1 and 
Appendix B); 
IV-E-l-bri2He)- Assigning 
containment levels for experiments with 
recombinant DNA from Class 3 
organisms(l] and assigning containment 
levels for experiments which increase 
the host-range and virulence of plant 
pathogens beyond that which occurs by 
natural genetic exchange. 
rV-E-l-b-{3). The Director is also 
responsible for the following actions. 
(The Director's decision will be 
transmitted to the RAC and IBC 
chairpersons and published in the 
Recombinant DNA Technical Bulletin): 
IV-E-l-b-(3H*)- Interpreting the 
Guidelines for experiments to which the 
Guidelines specifically assign 
containment levels: 
rV-E-l-b-(3}-(b). Determining 
appropriate containment conditions for 
experiments according to case 
precedents developed under Section IV- 
E-l-b-(2Hc). 
IV-E-l-b-(3Hc). Determining 
appropriate containment conditions 
upon case-by-case analysis of 
experiments explicitly considered in the 
Guidelines but for which no 
containment levels have been set (see 
Footnote 45 in Part V; Sections lU-C-l-a 
through -e; and Sections IU-C-2 and -3): 
IV-E-l-b-(3Hd). Authoriiing. under 
procedures specified by the RAC large- 
scale experiments (i.e.. involving more 
than 10 liters of culture) for recombinant 
DNAs that are rigorously characterized 
and free of harmful sequences (see 
Footnote 3 and Section I-D-6); 
IV-E-l-b-{3)-(e). Lowering 
contairunent levels for characterized 
clones or purified DNA (see Sections III- 
A-3-a and -b. Footnotes 3 and 41): 
rV-E-l-b-(3)-(f). Approving minor 
modifications of already certified host- 
vector systems. (The standards and 
procedures for such modincations are 
described in Section Il-D-2): and 
IV-E-l-b-(3)-{g). Decertifying already 
certiFied host-vector systems. 
rV-E-l-b-(3)-{h). Assigning 
containment levels for experiments in 
which both donor and recipient are 
nonpathogenic prokaryotes and/or 
nonpathogenic lower eukaryotes (see 
Section III-0-2). 
IV-E-l-b-{3)-(l). Adding new entries 
to the list of toxins for vertebrates (see 
Appendix G). 
IV-E-l-b-43Hl)- Approving the 
cloning of toxin genes in host-vector 
systems other than £. coU K-12 (see 
Appendix G). 
IV-E-l-b-(4). The Director shall 
conduct, support, and assist training 
programs in laboratory safety for 
Institutional Biosafety Committtee 
members. Biological Safety Officers. 
Principal Investigators, and laboratory 
staff. 
rV-E-l-b-{5). The Director, at the end 
of 36 months from the time these 
Guidelines are promulgated, will report 
on the Guidelines, their administration, 
and the potential risks and benefits of 
this research. In doing so. the Director 
will consult with the RAC and the 
Federal Interagency Committee. Public 
conunent will be solicited on the draft 
report and taken into account in 
transmitting the final report to the 
Assistant Secretary for Health and the 
Secretary, HHS. 
IV-E-2. Recombinant Advisory 
Committee. The NIH Recombinant DNA 
Advisory Committee (RAC) is 
responsible for carrying out specified 
functions cited below as well as others 
assigned under its charter or by the 
Secretary, HHS. the Assistant Secretary 
for Health, and the Director, NIH. 
The members of the committee shall 
be chosen to provide, collectively 
expertise in scientific fields relevant to 
recombinant DNA technology and 
biological safety— e.g.. microbiology, 
molecular biology, virology, genetics, 
epidemiology, infectious diseases, the 
biology of enteric organisms, botany, 
plant pathology, ecology, and tissue 
culture. At least 20 percent of the 
members shall be persons 
knowledgeable in applicable law. 
standards of professional conduct and 
practice, public attitudes, the 
environment, public health, occupational 
health, or related fields. Representatives 
from Federal agencies shall serve as 
nonvoting members. Nominations for the 
RAC may be submitted to the NIH 
Office of Recombinant DNA Activities. 
Bethesda. Md.. 20205. 
All meetings of the RAC will be 
announced in the Federal Register, 
including tentative agenda item. 30 days 
in advance of the meeting, with final 
agendas (if modified) available at least 
72 hours before the meeting. No item 
defined as a major action under Section 
rV-E-l-b-(l) may be added to an 
agenda after it appears in the Federal 
Register. 
IV-E-2-a. The RAC shall be 
responsible for advising the Director, 
NIH. on the actions listed in Section IV- 
E-l-b-0)and(2). 
IV-E^. The Office of Recombinant 
DNA Activities. ORDA shall serve as a 
focal point for information on 
recombinant DNA activities and provide 
advice to all within and outside NIH, 
including Institutions. Biological Safety 
Committees. Principal Investigators. 
Federal agencies. State and local 
governments, and institutions in the 
private sector. ORDA shall carry out 
such other fun> as ma\ be 
delegated to it by the Director, NIH, 
including those authorities described in 
Section IV-E-l-b-(3). In addition. 
ORDA shall be responsible for the 
following: 
lV-E-3-a. Review and approval of 
Institutional Biosafety Committee (IfiC) 
membership; 
IV-E-3-b through IV-E-3-c-(3). 
[Deleted] 
rV-E-c-(4). Publish in the Federal 
Register. 
IV-E-c-(4)-(a). Announcements of 
Recombinant DNA Advisory Committee 
(RAC) meetings and agendas 30 days in 
advance, with publication of the 
Director's proposed decision for 30 days 
of public and Federal agency comment 
followed by a published response, on 
any action listed in Section IV-E-l-(b)- 
(1); and 
lV-E-3-c-(4)-(b). Announcements of 
RAC meetings and agendas 30 days in 
advance of any action listed in Section 
IV-E-l-b-{2). 
Note. — If the agenda for an RAC meeting is 
modified, ORDA shall make the revised 
agenda available to anyone, upon request, at 
least 72 hours in advance of the meeting. 
rV-E-3-c-(5). Publish the 
Recombinant DNA Technical Bulletin; 
and 
rV-E-3-c-(6). Serve as executive 
secretary to the RAC. 
IV-E-4. Other NIH Components. 
Other NIH components shall be 
responsible for. 
IV-E-4-a. [Deleted] 
IV-E-4-b. Certifying P4 facilities, 
inspecting them periodically, and 
inspecting other recombinant DNA 
facilities as deemed necessary; and 
IV-E-4-C. Announcing and 
distributing certified HV2 and HV3 host- 
vector systems (see Section Il-E-3). 
(See Administrative Practices 
Supplement for additional information 
on the administrative procedures of 
ORDA and other NIH components.) 
IV-F. [Deleted] 
IV-G. Compliance. As a condition for 
NIH funding or recombinant DNA 
research. Institutions must ensure that 
such research conducted at or 
sponsored by the Institution, 
irrespective of the source of funding, 
shall comply with these Guidelines. The 
policies on noncompliance are as 
follows; 
IV-C-1. All NIH-funded projects 
involving recombinant DNA techniques 
must comply with the NIH Guidelines. 
Noncompliance may result in (i) 
suspension, limitation, or termination of 
financial assistance for such projects 
and of NIH funds for other recombinant 
DNA research at the Institution, or (ii) a 
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